MAUDE Adverse Event Report: ALCON CLEAR CARE CLEANING SOLUTION; CONTACT CLEANING SOLUTION

Device Problem Insufficient Information (3190)

Patient Problems Red Eye(s) (2038); Swelling (2091); Blurred Vision (2137); Burning Sensation (2146)

Event Date 08/11/2016

Event Type  Injury  

Event Description

My optician suggested that i may be experiencing a reaction to my typical saline solution.While at (b)(6) i grabbed the box next to my former which i believed had a small bottle of "saline" to throw in my purse.I tossed the small bottle into my purse a few weeks ago.Today while driving my left contact lens came out due to dryness.I pulled into a parking lot and opened the bottle and poured it over the lens.Once the lens was moistened i inserted into my eye and immediately felt a terrible burning.I couldn't open my left eye and i ran into a dance studio and flushed my eye repeatedly for 20 minutes.I drove home and began flushing my eye again.It was a bright red mess and i was barely able to open it.It has been 10 hours since this incident and my vision is still not clear.

• Brand Name: CLEAR CARE CLEANING SOLUTION
• Type of Device: CONTACT CLEANING SOLUTION
• Manufacturer (Section D): ALCON
• MDR Report Key: 5881878
• MDR Text Key: 52493588
• Report Number: MW5064112
• Device Sequence Number: 1
• Product Code: LPN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 91